CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
CPAP treatment +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01554527
NCT01554527N/ACompleted

Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children

University of Michigan·interventional·Posted Mar 15, 2012·Updated Jan 14, 2019

In Brief

A clinical study evaluating CPAP treatment and No CPAP treatment for Sleep Apnea, Obstructive and 4 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.

Study Details

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2012
Enrollment StartMar 1, 2012
Primary CompletionOct 29, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.3 years ago

Interventions

CPAP treatmentprocedure

6 months of treatment with PAP (CPAP or BPAP)

No CPAP treatmentother

Children randomized to the comparison group will receive routine care